Empower Your Medical Device Organization

Embark on a transformative journey with our ISO 13485:2016 handbook, tailored to guide organizations like yours in excelling in quality management. Address your compliance challenges head-on and unlock the path to operational excellence. Let's elevate your standards together!

Comprehensive Curriculum

5 Chapters · 20 Lessons

  1. 1

    Introduction to ISO 13485:2016

    1. (Included in full purchase)

      Understanding ISO 13485

    2. (Included in full purchase)

      Benefits of Compliance

    3. (Included in full purchase)

      Briefing Document: ISO 13485:2016 – Quality Management System for Medical Devices

    4. (Included in full purchase)

      ISO 13485:2016 Study Guide

  2. 2

    Developing a Quality Management System

    1. (Included in full purchase)

      Key Components of QMS

    2. (Included in full purchase)

      Document Control

    3. (Included in full purchase)

      Briefing Document: Quality Management Systems (QMS) and ISO 13485:2016 for Medical Devices

    4. (Included in full purchase)

      Quality Management System (QMS) Study Guide

  3. 3

    Implementing ISO 13485:2016

    1. (Included in full purchase)

      Planning for Implementation

    2. (Included in full purchase)

      Training and Awareness

    3. (Included in full purchase)

      Briefing Document: Implementing ISO 13485:2016 and Building a Quality Culture

    4. (Included in full purchase)

      ISO 13485:2016 Implementation Study Guide

  4. 4

    Maintaining Quality Management System

    1. (Included in full purchase)

      Internal Audits

    2. (Included in full purchase)

      Corrective and Preventive Actions

    3. (Included in full purchase)

      Briefing Document: Internal Audits, Nonconformity Management, and Corrective/Preventive Actions in ISO 13485:2016

    4. (Included in full purchase)

      Internal Auditing & Corrective/Preventive Action Study Guide

  5. 5

    Preparing for Certification

    1. (Included in full purchase)

      Choosing a Certification Body

    2. (Included in full purchase)

      Mock Audits and Readiness Checks

    3. (Included in full purchase)

      Briefing Document: Navigating ISO 13485 Certification

    4. (Included in full purchase)

      ISO 13485 Certification Study Guide

Ready to Transform Your Quality Management System?

Take the first step towards compliance and excellence with our ISO 13485:2016 handbook. Empower your organization today!

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